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Three studies have been conducted to evaluate the safety and efficacy of Ventolin HFA in patients under 4 years of age and the findings are described below. The data from pediatric patients are based upon 1 clinical trial in which 46 patients with asthma 4 to 11 years of age were treated with Ventolin HFA 2 inhalations 4 times daily for 2 weeks’ duration. Since the efficacy of Ventolin HFA has not been demonstrated in children between birth and 48 months of age, the safety of Ventolin HFA in this age-group cannot be established. Palpitation and dizziness have also been observed with Ventolin HFA. Ventolin HFA or placebo HFA was delivered with either an AeroChamber Plus® Valved Holding Chamber or an Optichamber® Valved Holding Chamber with mask 3 times daily. If the patient needs more doses of Ventolin HFA than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.

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